The following data is part of a premarket notification filed by Terran Biomedical Instruments with the FDA for Terran Biomechanical Analysis System.
| Device ID | K851133 |
| 510k Number | K851133 |
| Device Name: | TERRAN BIOMECHANICAL ANALYSIS SYSTEM |
| Classification | Device, Sensing, Optical Contour |
| Applicant | TERRAN BIOMEDICAL INSTRUMENTS 1520 24TH. ST. NE Salem, OR 97301 |
| Contact | Scott Elliot |
| Correspondent | Scott Elliot TERRAN BIOMEDICAL INSTRUMENTS 1520 24TH. ST. NE Salem, OR 97301 |
| Product Code | LDK |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-21 |
| Decision Date | 1985-06-19 |